Since 2001, Lotus has honed its analgesic study design and execution process and is now nationally recognized as the leader in analgesic clinical research. We have developed proprietary materials for patient education and staff training that consistently increase effect size by minimizing variability and placebo response in analgesic clinical trials. Following the study protocol and producing "clean and organized" data is only the beginning of our responsibility as a site. At Lotus, we recognize that analgesic protocols have several grey areas and that there is much that can be done outside the study protocol to improve the clarity of the resultant data including subject education, staff training, controlling the number of raters and minimizing the number of investigators/proceduralists.
Each pain model has its own complexities and nuances. Although the populations are unified because they are all associated with pain syndromes, the pathologies are very different and as such the patient populations are unique. That being the case, each model requires a tailored approach. For example, recruitment of a population of patients that have post-herpetic neuralgia requires a completely different strategy than accrual of patients into a total knee replacement study. The same argument holds true for patient retention, clinical management and data collection.
Clinical Research Experience
ACUTE PAIN – SOFT TISSUE
- Hernia Repair
- Laparoscopic Cholecystectomy
- Colon Surgery
- Keloid Removal
- Tubal Ligation
ACUTE PAIN – ORTHOPEDIC
- Total Hip Replacement
- Total Knee Replacement
- Shoulder Arthroscopy
- Knee Arthroscopy
- Hip Arthroscopy
CHRONIC PAIN – NEUROPATHIC
- Diabetic Peripheral Neuropathy
- Post-Herpetic neuralgia
- Radicular Low Back Pain
CHRONIC PAIN – NON-NUEROPATHIC
- Non-Radicular Low Back Pain
ANALGESIC PHASE I/PROOF-OF CONCEPT
POST-OPERATIVE NAUSEA AND VOMITING
Lotus operates a 40-bed, Phase 1-3 privately owned research unit located on the 675-bed Huntington Hospital campus in Pasadena, California. Our specialties include Acute Pain, Chronic Pain, Analgesic Phase 1/Proof-of Concept and Opioid-Induced Constipation. We have 35 full-time employees and function both as a clinical research unit and as an analgesic CRO.
Since our inception, Lotus has been inspected by the FDA on 3 occasions. All three of these not-for-cause audits reported positive comments with no 483s issued. Our position inside a major metropolitan hospital provides unprecedented access to all medical specialties / therapeutic areas and state of the art medical equipment. Our geographical location in greater Los Angeles County allows us to easily recruit from a large and ethnically diverse population of subjects.
Nearly all hospital based research units are owned by the parent institution, which inevitably leads to an extended contracting process and a painstaking local IRB review cycle. Lotus has a unique private ownership business model which allows it to contract independently and utilize a central IRB, bypassing institutional bureaucracy for rapid study starts.
Dr. Neil Singla is a nationally recognized key opinion leader in analgesic protocol design and implementation. His experience in protocol design has been garnered from multiple regulatory contacts and meetings with the FDA over the past 12 years. He has published extensively and is a frequent lecturer for physicians, pharmaceutical companies and medical research institutes throughout the country. The main focus of Dr. Singla's academic endeavors has been to analyze and understand how the inherent variability in subjective endpoint analgesic clinical trials can be minimized. He has developed novel techniques for patient education designed to minimize variability, reduce placebo response and increase effect size.
Properly educated staff can stabilize patient expectations and reduce placebo response. At Lotus we believe that following the protocol is only the beginning of our responsibility. Subjective endpoint clinical trials require finesse and critical thinking that move beyond a robotic examination of protocol mandated duties. All members of our staff are required to understand the primary endpoint of each investigation and its method of calculation so that they can focus their efforts on obtaining nonbiased and accurate data.
Lotus has the nation’s largest analgesic database with over 13,000 volunteers. We work closely with private practice physicians for both access to patients in their databases and for their therapeutic expertise. In addition to multiple physician referral sources, our dedicated recruitment staff supports broad community outreach and a full-time clinical research call center to facilitate patient recruitment. The Lotus patient recruitment team has a track record of success and years of experience. Our commitment to this diverse and successful recruitment strategy is secondary to the knowledge that patient recruitment and retention is the key to successful clinical trial conduct.
MAXIMIZING EFFECT SIZE - At Lotus, we have spent years honing our clinical trial skills so that we can produce the greatest standardized effect size possible. We do this because the standardized effect size, or SES is the key variable that determines the result of a clinical investigation. The inherent efficacy of the study molecule is only one factor that contributes to the probability of a positive clinical trial. There are many things that the site and the sponsor can do collaboratively to optimize the clinical trial and increase the probability of success. In order for any clinical trial to be positive, active medication must separate from placebo without significant variability. Many analgesic studies are negative even though the investigational product has known efficacy because the SES has been artificially lowered due to experimental error.
At Lotus, we take great pains to examine and consistently improve the SES generated from our analgesic investigations by: reducing placebo response, optimizing treatment response and minimizing variability. Examining, understanding and improving our analgesic effect size is our core mission. We have a significant amount of published data indicating that the Lotus SES is superior to the SES generated at other analgesic research sites (see www.lotuscr.com for links and details).
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